Johnson and Johnson's COVID-19 Vaccine Launches in South Africa
The South Africa Department of Health announced on February 17, 2021, an early access COVID-19 vaccine rollout to healthcare workers. South Africa secured the single-dose Johnson & Johnson (Janssen) COVID-19 vaccine for use with up to 500,000 healthcare workers in 18 public sector hospitals across all nine provinces.
The single-dose Janssen COVID-19 vaccine's safety and efficacy were assessed in the international Phase 3 study, which was conducted across Latin America, the USA, and South Africa. Around 7,000 South Africans participated; some were exposed to the 501.V2 coronavirus variant.
The South African part of the trial showed this vaccine provided 57% protection against moderate-severe COVID-19 disease, 85% protection against severe disease, and 100% protection against death.
The long-term follow-up study is ongoing, as is required for the process of regulatory approval by the South African Health Products Regulatory Authority (SAHPRA) for commercial or emergency use. However, since the vaccine's safety and efficacy have already been proven, the current rollout is being conducted under The Sisonke Open-Label Program.
The vaccine is not available to pregnant women during this initial stage. This is common practice when vaccines are not yet fully licensed, such as during clinical trials. However, The Janssen COVID-19 vaccine can be safely used in breastfeeding women, stated the Sisonke Program.
Janssen is the vaccine division of the Johnson and Johnson companies.